Prostate CancerI-gel90NCT01826565
Comparison of Two Insertion Technique of I-gel
A study testing Rotational technique in people with Prostate Cancer and Prostate Tumor, run by Seoul National University Hospital.
Trial summary
To evaluate the efficacy of rotational technique in the insertion of i-gel Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Prostate Cancer, Prostate Tumor, Bladder Cancer
- What is being tested?
- Rotational technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM
Who cannot join
- History of recent postoperative sore throat
- History of difficult airway
- Mouth opening < 2.5 cm
- Emergency operation
About this study
Official title: Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation
To evaluate the efficacy of rotational technique in the insertion of i-gel
Read the detailed description
The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.
- Conditions
- Prostate Cancer, Prostate Tumor, Bladder Cancer, Bladder Tumor
- Being tested
- Rotational technique
- Keywords
- success
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational techniqueProcedure or surgery
Also called 90 degree rotation technique
90 degree rotation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | i-gel will be inserted without rotation |
| Rotation | Experimental | Rotational technique applied Receives: Procedure: Rotational technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of insertion
check oropharyngeal leakage at pressure 12 cmH2O
Measured: up to 30 min.
Secondary outcomes (1)
postoperative sore throat
severe/moderate/minimal/none
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Pyung Park, MD PhD, Principal investigator, Seoul National University of HospitalHyun-Chang Kim, MD, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826565
- Sponsor's protocol ID
- HPPark
- Acronym
- I-gel90
- Status last verified
- May 2013
- First submitted
- 19 Mar 2013
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation
- ClinicalTrials.gov ID
- NCT01826565
- Acronym / sponsor ID
- I-gel90 / HPPark
- Conditions
- Prostate Cancer, Prostate Tumor, Bladder Cancer, Bladder Tumor
- Keywords
- success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of rotational technique in the insertion of i-gel
Detailed description
The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –i-gel will be inserted without rotation |
| Rotation | Experimental | Procedure: Rotational techniqueRotational technique applied |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM
Key exclusion criteria (4 listed)
- History of recent postoperative sore throat
- History of difficult airway
- Mouth opening < 2.5 cm
- Emergency operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotational techniqueAlso: 90 degree rotation technique90 degree rotation | Procedure or surgery | Rotation |
Primary outcome
The success rate of insertion
Time frame: up to 30 min.
check oropharyngeal leakage at pressure 12 cmH2O
1 secondary outcome
postoperative sore throat
Time frame: up to 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Pyung Park, MD PhD principal investigator
Seoul National University of Hospital
Hyun-Chang Kim, MD principal investigator
Seoul National University of Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Rotational technique in people with Prostate Cancer and Prostate Tumor, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of insertion (time frame: up to 30 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.